Associate Director, Clinical Manufacturing

Role Overview

• Lead internal and external cross ‑ functional teams to ensure timely , uninterrupted clinical supply of small ‑ molecule, biologics, and gene therapy drug substance and drug product.
• Oversee manufacturing activities for small ‑ molecule, biologics, and gene therapy programs in partnership with PDCS leadership.
• Guide technical teams to achieve successful New Product Introduction and Technology Transfer, including resolving complex issues that could impact timelines.
• Partner with Development and Commercial Manufacturing to support smooth product transitions to/from Clinical Manufacturing.
• Collaborate with Supply Planning to develop supply models and manufacturing schedules that reflect program requirements, technical capabilities, and regulatory considerations across all modalities, including gene therapy.
• Lead vendor identification and selection for novel technologies and complex manufacturing processes, including viral vector, AAV, or other gene therapy platforms.
• Negotiate master supply agreements, project plans, and statements of work with external partners.
• Recommend strategic clinical manufacturing plans across all phases of clinical development, including gene therapy programs requiring specialized capabilities.
• Manage drug substance and drug product budgets, including externally sourced gene therapy manufacturing.
• Support process improvement initiatives, tech transfers, and scale ‑ up activities, including for gene therapy modalities with unique regulatory and technical needs.
• Partner with Quality Assurance to ensure timely batch release, deviation resolution, and CAPA implementation.
• Provide regular operational updates to senior leadership.
• Establish and track KPIs to assess CMO performance, clinical material utilization , and performance across gene therapy manufacturing partners.
• Participate in business reviews, joint steering committees, and cross ‑ functional project team meetings.
• Travel up to 10% as required.

Requirements

• 8+ years of experience in cGMP manufacturing for small ‑ molecule, API, biologics, and/or gene therapy drug substance or drug product.
• Proven experience managing CMOs and providing technical oversight, including experience with gene therapy manufacturing, viral vector processes, or related novel modalities.
• Experience with device/combination products, biologics, cell and gene therapies, or other emerging technologies strongly preferred.
• Demonstrated ability to influence decision makers internally and externally.
• Strategic thinker with strong cross ‑ functional insight and the ability to evaluate and mitigate complex manufacturing risks.
• Experience leading cross ‑ functional project teams (e.g., CMC teams).
• Demonstrated leadership in ambiguous or novel technical areas, including gene therapy programs with evolving regulatory frameworks.
• Strong understanding of cGMP and modality ‑ specific regulatory requirements, including those applicable to gene therapy.
• Strong project management, communication, and negotiation skills.
• Proactive in identifying and mitigating supply risks.
• BS in engineering or science (or equivalent experience).

Benefits

• Short-term incentive bonus opportunity
• Eligibility to participate in our equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans